Full Press Release Details
CNS Provides Update on Development
HOUSTON, May 27 2020 /PRNewswire/ -- CNS
Pharmaceuticals, Inc., (Nasdaq: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing
in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided
an update on the development of WP1122. As previously announced, CNS entered into an agreement with WPD Pharmaceuticals for the
development of several preclinical drug candidates for antiviral indications, including WP1122, in certain territories. WPD Pharmaceuticals
previously licensed rights to WP1122, from Moleculin Biotech, Inc. (Moleculin) for certain territories.
Today, Moleculin announced that on May
1, 2020 it submitted a request to the US Food and Drug Administration ("FDA") for a Pre-IND Meeting to seek guidance
on requirements for submitting an Investigational New Drug ("IND") application to study its drug candidate, WP1122,
in a clinical trial for patients with COVID-19, and that on May 6, 2020, the FDA granted Moleculin's meeting request, and
indicated that its goal for providing written responses is June 30, 2020, but that it plans to act early on this meeting request,
provided there are no significant deficiencies in the Pre-IND package or unexpected shifts in its work priorities. Moleculin further
stated that it may be able to submit its IND application in the second half of this year. More specific timing will depend upon
the guidance Moleculin receives from its Pre-IND Meeting with the FDA.
Additionally, Moleculin announced that
it engaged ImQuest BioSciences ("ImQuest") and the Illinois Institute of Technology Research Institute ("IITRI").
IITRI is initially focused on preclinical toxicology testing to help determine whether WP1122 can be considered safe for testing
in humans. ImQuest conducted two rounds of preclinical assessment of the potential for WP1122 to address COVID-19. The first round
was to demonstrate whether or not the improved pharmacology of WP1122 gave it a greater therapeutic window than 2-DG. The second
round was to demonstrate the ability of WP1122 to inhibit coronavirus production in mammalian cell culture. The testing done by
ImQuest was performed on a surrogate of SARS-CoV-2 called Human coronavirus strain 229E ("HCoV-229E").
Although these in vitro results should
not be considered conclusive or indicative of what will happen in vivo, the initial results, received by Moleculin on May 4, 2020,
showed that both 2-DG and WP1122 have an antiviral effect on HCoV-229E. WP1122 displayed a greater therapeutic index than 2-DG,
while the virus yield reduction assay demonstrated a 5 to 10-fold inhibition of coronavirus
production by WP1122 and 2-DG when compared to untreated virus control. Moleculin
is having ImQuest repeat its tests to provide additional confidence in its findings. In addition to having ImQuest repeat their
tests, Moleculin announced that it is arranging for additional in vitro testing to include additional human cell lines and the
use of a validated SARS-CoV-2 assay, as well as testing against other pathogenic viruses. The Company cautions readers that these
results are initial and are not conclusive.
Under the terms of the development agreement
with WPD Pharmaceuticals, CNS agreed to fund a portion of the development costs of WP1122 and other drug candidates for antiviral
indications in exchange for certain economic rights. CNS made an upfront cash payment of $225,000 and committed to a milestone
payment of $775,000 to WPD Pharmaceuticals upon the successful completion of a Phase 2 study. In return, CNS is entitled to receive
50% of the net sales, less WPD's license costs, of resulting commercial products in WPD's licensed territories, other than Poland.
Those territories include 29 countries in Europe and Asia, including Russia.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel
treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed
for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin
chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin
in GBM which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free
survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders.
One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020,
CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner
undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug
candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the
chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, please visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release
are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements
include, without limitation, whether the results of Moleculin's subsequent testing will statistically support the initial
ImQuest results, and Moleculin's ability to file an IND in the second half of 2020, if at all. These statements relate to
future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking
statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed
or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including
''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,''
''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify
these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and
other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most
recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our
Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak
only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco